This is a three-part Phase Ia study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of SYHA1805.
This trial is divided into three parts: 1) The first part: Four Chinese healthy subjects will be included in the pre-test group to evaluate the safety, tolerability and pharmacokinetics after taking SYHA1805 tablets; 2) The second part: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics, several single ascending doses of SYHA1805 tablets or matching placebo tablets will be randomly administered to 24 Chinese healthy subjects under fasting condition; 3) The third part :To evaluate the food effect on the pharmacokinetic characteristics, a single dose SYHA1805 tablets will be administered to 12 Chinese healthy subjects under fed or fasted condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Oral tablets of SYHA1805 with several doses
Oral tablets of placebo with matching several doses
Number of Participants with One or More Serious Adverse Event(s) (SAEs) or non-serious adverse events (AEs) Considered by the Investigator to be Related to Study Drug Administrationorally
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through Day 28
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) after administration of of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals
Time frame: Baseline through Day 28
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) after administration of of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals
Time frame: Baseline through Day 28
Time to maximum plasma concentration(Tmax)
Time to maximum plasma concentration(Tmax)after administration of of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals
Time frame: Baseline through Day 28
Half time (t1/2)
The half time of SYHA1805 after administration are calculated under fasting conditions or under the food effect of high-fat, high-calorie meals
Time frame: Baseline through Day 28
Apparent clearance (CL/F)
To assess the apparent clearance (CL/F) after administration of SYHA1805 under fasting conditions or under the food effect of high-fat, high-calorie meals
Time frame: Baseline through Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To evaluate the ECG result of single doses of SYHA1805 administered orally
To analysis of the QT Interval after administration of of SYHA1805
Time frame: Baseline through Day 28